April 27, 2018
Almost a year has passed since the Centers for Medicare & Medicaid Services (CMS) issued a compliance memorandum telling healthcare systems to perform risk assessments and implement water safety programs to prevent patients from acquiring Legionnaires’ disease (LD).
It’s making a difference in terms of infection preventionists putting Legionella on their radar and hospitals seeking testing and risk assessment advice, says Janet Stout, PhD, president of the Special Pathogens Laboratory in Pittsburgh.
She predicted as much last year after the CMS memo was issued right before the annual APIC conference, turning Stout’s relatively pedestrian Legionella presentation into “must-see” IC.
Facing a packed crowd seeking compliance guidance, Stout finally was no longer a voice in the wilderness.
After investigating LD since that first, titular outbreak in 1976 at a Legionnaires’ convention in Philadelphia, Stout was ready to share a wealth of accumulated information.
“When I speak at something like that — there are also other sessions going on — I expect something like 50 or 100 people,” she says. “It was standing room only. There must have been 500 to 600 people there. That was a dramatic visual depiction of the impact of the CMS memorandum. When CMS speaks, every healthcare facility listens.”
The CMS outlined the situation in no uncertain terms. The compliance directive was needed because a review of the increasing number of LD outbreaks in 2000-2014 showed that 15% were in hospitals and 19% in long-term care.
“The CMS expects Medicare-certified healthcare facilities to have water management policies and procedures to reduce the risk of growth and spread of Legionella and other opportunistic pathogens in building water systems,” the agency emphasized.1
Primarily caused by Legionella pneumophila serogroup 1, LD outbreaks in healthcare are typically traced to the waterborne bug becoming aerosolized and inhaled in shower mist. Faucets, spas and baths, cooling towers, decorative fountains, and medical equipment also have been implicated.
Hospital Infection Control & Prevention asked Stout to update the situation in the following interview.
There is no reason to be afraid to evaluate the presence of Legionella. What gets people stuck is that they believe for some reason that you can completely eliminate a naturally occurring bacteria from complex water systems in hospitals and long-term care facilities.
You can’t. You can control it, which is sufficient to manage or prevent disease. That is the “zero” worth looking for. We are looking for zero cases of LD, not zero bacteria.
HIC: While there often is resistance to regulation in clinical settings, you have made the case that this CMS action is a good thing.
Stout: When the memorandum came out last year, I emailed the contact person and said, “Congratulations on doing something that will dramatically move the prevention of healthcare-acquired LD forward — forward in a way that will be much more substantive than the ASHRAE standard that came out in 2015, or even the CDC water management toolkit.
First of all, the CMS memo was short and to the point. You must have a risk assessment and water management plan to address the risk of Legionella in your facility, and you need to have measures that demonstrate control, including testing for pathogens like Legionella.
HIC: Legionella has come to national attention following outbreaks, but subsequently fades back again. Will this regulatory aspect finally set prevention as a priority?
Stout: The only caveat I will say is that it has the potential to dramatically reduce healthcare-acquired LD. In the Special Pathogens Lab, we do the testing for Legionella and other organisms, and do consultations to help people comply with CMS and other standards.
We have seen a dramatic uptick in requests for testing, risk assessments, and water management plans. Usually with these things there are early adopters, people in the middle, and later adopters. With ASHRAE, even though it was an industry best practice, it was still a voluntary standard. CMS is not voluntary.
August 15, 2017
The deadline for comments on revisions to ASHRAE Guideline 12, Minimizing the Risk of Legionellosis Associated with Building Water Systems, is Monday, September 11.
Guideline 12 provides practical information on controlling Legionella and implementing ANSI/ ASHRAE 188, Legionellosis: Risk Management for Building Water Systems. Like ASHRAE 188, it is for building owners of human-occupied buildings and those involved in design, construction, installation, commissioning, management, operation, maintenance and service of centralized building water systems and components. To learn more, see ASHRAE's news release.
Download the proposed revised guideline here. Your input is critical to making this an accurate and user-friendly guideline. Your knowledge and experience will make a difference!
August 08, 2017
At 74, Bob Marks is grateful to be alive after collapsing at his Hempfield home last summer with an aortic dissection, a tear in the wall of the major artery carrying blood out of his heart.
Marks, a retired Lutheran pastor and registered nurse, said he's thankful for the flight team that got him to the hospital and the surgeons who saved his life at Allegheny General Hospital.
But he's begun to wonder whether the myriad complications that plagued his recovery — fatigue, night sweats, pneumonia, influenza and shingles — could be related to a rare form of bacteria called non-tuberculous mycobacterium, or NTM, found in heater-cooler devices used in open-heart surgery in about 60 percent of U.S. hospitals. The devices in question are known as Stockert 3T units....
...The case linking the rare infection to a specific device has been emerging for years in a medical detective saga spanning three continents.
Experts now believe NTM finds its way into operating suites when water in an internal tank in the device becomes contaminated. Although the water never comes into direct contact with patients, droplets can work their way into the internal workings of the device, be picked up by a fan, dispersed into the air and land on the patient undergoing surgery.
The trail that culminated in the latest warnings began with anecdotal reports of the rare infection out of Western Europe about a decade ago. In 2015, WellSpan York Hospital in Eastern Pennsylvania became the first U.S. hospital to identify such infections among patients who had undergone open-heart surgery there....
...Things reached critical mass this year with the release of a new study from the Special Pathogens Laboratory in Pittsburgh that found NTM in 33 of 89 units from 23 hospitals in 14 states; Washington, D.C.; and Canada sampled from July 2015 through March 2017. The lab, one of a handful in the United States that specializes in water-borne pathogens, also found four of the units colonized for Legionella, the bacteria associated with Legionnaire's Disease.
John Rhis, a microbiologist who is vice president of Laboratory Services at Special Pathogens Laboratory, made headlines in June when he released his findings at the national conference of the Association for Infection Control and Prevention.
“If the unit was responsible for contamination with (NTM), it makes sense that these other organisms were contaminating the sterile field as well,” Rhis said.
“I was shocked at the level of contamination we found. About 15 percent of the samples we tested were so heavily contaminated with bacterial or fungal overgrowth that they were uninterpretable. So, the actual number of positive tests might have been higher,” he said.
Rhis said the NTM infections are so rare that many hospitals would never have tested for it.
“That's why it took so long for this to be worked out. It's an unusual pathogen, and it's pretty amazing that the link was even made,” he said.
(Excerpt from TribLive)
August 07, 2017
Health officials across the state are trying to determine what's causing a 143% increase in cases of Legionnaires' disease, a respiratory infection that can be deadly, especially for people with weak immune systems.
"In the warm months, there is an increase in Legionnaires'," said Jennifer Eisner of the Michigan Department of Community Health. "At this point, no common source has been identified."
In June and July, 73 cases were confirmed. In the past three years, the average number of cases during those months was 30....
...Legionnaires' became an issue in the Flint water crisis. State health officials confirmed 91 cases, including 12 deaths, from the disease in Genesee County in a 17-month period in 2014-15. The cases spiked after the city switched its water source from the Detroit water system to the Flint River in April 2014.
Janet Stout, an associate professor at the University of Pittsburgh Swanson School of Engineering who has 30 years of experience studying the disease, concluded the problems with Flint's water were related to the increase in Legionnaires' cases — although she can't prove it. “It is like an emperor’s new clothes situation,” Stout told the Free Press last year. “Somebody has to say it.”
She said it's a "reasonable conclusion," given the link between poor water quality and Legionnaires' disease in scientific studies done elsewhere.
(Excerpt from Detroit Free Press)
Post-Gazette article spurs Rep. Murphy to ask new CDC head to take another look at Legionnaires' investigation
July 27, 2017
CDC was forced to correct journal article about Pittsburgh VA Legionnaires' outbreak
The new head of the Centers for Disease Control and Prevention told U.S. Rep. Tim Murphy on Tuesday afternoon that she would “look into” why the CDC had to correct a journal article about the Legionnaires’ outbreak at the Veterans Affairs Pittsburgh Heatlhcare System.
That promise from Brenda Fitzgerald, the former head of the Georgia Department of Public Health who was just appointed to the CDC on July 7, came after Mr. Murphy gave her a copy of the Post-Gazette’s July 23 article that examined why the CDC corrected the journal article — a rare and embarrassing move for researchers.
“The first thing I did was hand her [the Post-Gazette’s] latest article,” Mr. Murphy said in a phone interview after the meeting. “She told me she’s going to look into this.”
Dr. Fitzgerald told Mr. Murphy she was unfamiliar with the issue, but Mr. Murphy explained that it was an important issue that deserved additional attention.
The CDC was forced to make a correction to the Clinical Infectious Diseases journal article last month after the Post-Gazette ran a two-part series in December about the CDC’s investigation and reporting of the outbreak.
The Post-Gazette’s stories demonstrated that the CDC’s investigators and leaders held biases before they began the 2012 investigation of the Legionnaires’ outbreak at the Pittsburgh VA. The outbreak sickened 22 veterans and led to the deaths of six of them. Those biases led to questionable investigation techniques and alteration of data in the journal article from what was originally discovered during the investigation.
“This is a huge breach of science [in an outbreak] that led to deaths,” Mr. Murphy said in an interview Tuesday.
The investigators and leaders openly expressed bias against the copper-silver ionization system that the Pittsburgh VA used to combat Legionella in its water, as well as bias against two former VA researchers who are experts on Legionnaires’, Victor Yu and Janet Stout.
July 23, 2017
Journal editor said Post-Gazette series led to the change
[EXCERPT FROM THE PITTSBURH POST-GAZETTE; Sean D. Hamill:email@example.com or 412-263-2579 or Twitter: @SeanDHamill.]
In a rare move, the federal Centers for Disease Control and Prevention has corrected a journal article it authored about its investigation of the 2011 and 2012 Legionnaires’ outbreak at the Veterans Affairs Pittsburgh Healthcare System.
The editor of the Clinical Infectious Diseases journal said the correction last month in the 2015 article was the result of the Pittsburgh Post-Gazette’s series in December that revealed that CDC officials involved in the investigation held biases against two Legionnaires’ experts who used to work at the VA, as well as the disinfectant system that the VA had been using to control Legionella.
That bias, the series disclosed, appears to have affected the way the VA not only investigated the outbreak — which sickened 22 veteransleading to the death of six of them — but how it ultimately reported its findings. It blamed the copper-silver ionization disinfectant system for the outbreak instead of the people who managed and maintained it for the VA.
Those findings contradicted a VA Inspector General report in 2013 that found that the outbreak was due to poor management generally and poor maintenance of the copper-silver system specifically — not that the copper-silver system itself had failed. The system is considered the gold-standard in the industry.
“It seems here [the CDC employees] had an agenda with the way they did the article from the beginning,” said Robert Schooley, the journal’s editor and the head of the division of infectious diseases at the University of California at San Diego.
The biases were expressed by CDC officials in emails they sent to each other, which were obtained by the Post-Gazette through a Freedom of Information Act request . . .
. . . In the emails, CDC officials openly discussed their biases against copper-silver systems, as well as two researchers who used to work at the Pittsburgh VA and had long battled the CDC over a variety of issues related to Legionnaires’ disease, including copper-silver systems, which the researchers believe are effective.
In one email, Cynthia Whitney, the head of the CDC’s respiratory disease branch, said that because the outbreak was at the Pittsburgh VA where two Legionnaires’ researchers disliked by some CDC officials had worked, and because there was a copper-silver system in use there, investigating the outbreak would be “poetic justice.”
The two Legionnaires’ experts maligned by CDC officials in their emails, and representatives from the two copper-silver ionization manufacturers that worked with the Pittsburgh VA, all took issue with the journal article and the CDC’s attempt to minimize what it did.
“This is not an honest error,” said Janet Stout, the Legionnaires’ expert who now runs a private laboratory in Pittsburgh’s Uptown neighborhood with her colleague, Victor Yu. “The CDC’s 2015 article had an agenda to discredit copper-silver ionization. Now we can see the CDC deliberately misrepresented their lab data only to support their view. They took their whole experiment and cherry-picked data.”
“That really is misconduct,” she said.
Dr. Yu agreed: “When I see an error like that, I believe it was deliberate. They had an experiment that showed it worked, then they said it didn’t.”
Special Pathogens Laboratory Hires Technical Director with Legionella Water Management and Engineering Expertise
July 21, 2017
Special Pathogens Laboratory welcomes back Frank P. Sidari III, PE, BCEE, as technical director for SPL Consulting Services.
Frank P. Sidari III returns to Special Pathogens Laboratory after serving as an engineering project management and coordinator for capital improvements of water treatment and distribution systems at Pittsburgh Water and Sewer Authority. He brings significant water and wastewater experience from his work at major engineering firms including URS and ARCADIS/Malcolm Pirnie. In those positions, he conducted all phases of water and wastewater projects including, client and proposal development, studies, field services, detailed design and specification, permitting, and construction services.
Dr. Janet E. Stout, director of Special Pathogens Laboratory and research associate professor at the University of Pittsburgh Swanson School of Engineering, says, “We're excited that Frank's returning to SPL in this new role to advance our engineering capacities and research in managing the risk of Legionella in water systems.”
A registered professional engineer, board certified environmental engineer and certified construction document technologist, says he is excited to refocus his efforts on managing risk of Legionella in water systems.
"With mounting industry and regulatory direction on managing Legionella in building water systems, I am excited to return to SPL to assist our clients with the design of new systems and management of existing facilities," says Sidari.
Sidari published the first field evaluation of chlorine dioxide disinfection of a hospital campus water system to control Legionella pneumophila, which appeared in Journal of the American Water Works Association. In 2014, he was awarded the Consulting-Specifying Engineer’s 40 under 40 award for combining engineering expertise with a specialization in water quality and Legionella.
July 20, 2017
If prosecutors are looking for evidence to prove manslaughter charges against five government officials charged with the death of a man they say contracted Legionnaires' disease from Flint water, they may have to look further than his death certificate.
The certificate, filed in the Genesee County Clerk's Office, lists the 85-year-old Genesee Township man's cause of natural death as "end stage congestive heart failure." Neither Legionnaires' disease nor Legionella is listed on the county's record of Robert Skidmore's death.
MLive-The Flint Journal was not able to reach Genesee County Medical Examiner Brian Hunter for comment.
However, Oakland County Medical Examiner Dr. Ljubisa J. Dragovic said that, if foul play is not suspected in a death and an autopsy is not performed on a body, causes of death are often "educated guesses" and that mistakes can be made.
"Each and every death is different, and obviously there are questions with each death, and certainly if there's no autopsy," Dragovic said....
But Skidmore's listed heart failure can be an indication that he was at a higher risk to contract Legionnaires' disease, said Dr. Janet Stout, president and director of the Pennsylvania-based Special Pathogens Laboratory and an expert in legionella.
Cancer, kidney failure, respiratory failure or heart failure -- as in Skidmore's case -- can render a person more susceptible to contracting Legionnaires', Stout said.
(Excerpt from MLive)
July 07, 2017
The Southwestern Veterans' Center has confirmed it’s had low levels of Legionella bacteria in its water.
Channel 11 learned there are still precautions being taken there with patients and staff drinking bottled water, while retesting is going on after low levels of Legionella were found there.
11 Investigates uncovered Tuesday that a patient at the Southwestern Veterans' Center tested positive for Legionnaires' Disease on June 8 and was admitted to the VA Hospital in Oakland for treatment....
"In order to get Legionnaires' Disease, you have to be exposed to the bacteria from the water, it has to get into your lungs and the lungs of the individual have to be susceptible to an infection,” said Dr. Janet Stout, an expert in Legionnaires' Disease at Special Pathogens Laboratory in Pittsburgh. Stout told Channel 11 a long-term disinfection plan is as important as an aggressive cleaning when the bacteria is first discovered.
"Those single knock downs, Legionella comes right back up, so it grows again even though you've controlled it initially,” Stout said.
(Excerpt from WPXI)
June 15, 2017
A device used routinely in open chest surgery may have put many more patients at risk of infection from a rare but deadly form of bacteria than earlier believed, according to a study by a Pittsburgh researcher released Wednesday.
The research, released at a national conference of infection prevention experts in Portland, Ore., has prompted at least one local hospital system, Allegheny Health Network, to begin notifying about 3,000 patients who were involved in such surgeries at either Allegheny General Hospital or West Penn Hospital since 2012. UPMC said it is not notifying its patients.
The problem with the device — heater-cooler units that are used to warm or cool patient bodies — has been known since early 2015, after research in European countries first linked infections in patients to contamination in one particular type of unit, the Stockert 3T made by LivaNova of Germany.
U.S. regulators have since found the same problem they suspect led to the infections from the Stockert 3T — cooling fans aerosolizing leaking water — was possible with other manufacturers as well. Almost all of the reported cases of infection have come from the Stockert 3T, but a few have been associated with other manufacturers’ units as well.
The new study by Jack Rihs, head of laboratory services at Special Pathogens Laboratory in the Pittsburgh Bluff neighborhood, found that the rate of contamination in heater-cooler units was much higher than the U.S. Food and Drug Administration believed last fall when it said up to 500,000 people might be at risk.
In samples of water from the units — all of them Stockert 3Ts, which once made up 60 percent of the market in the U.S. — Mr. Rihs found that 33 of 89 of the heater-cooler units he tested from 23 states, the District of Columbia and Canada tested positive for mycobacterium chimaera.
“I was surprised that so many were positive,” Mr. Rihs said, “because [M. chimaera] is such a rare pathogen and to find so many in these devices all over the U.S. is unusual.”
(Excerpt from Pittsburgh Post Gazette)